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2023 Switzerland Medical Device Registration: Who, When & How

    https://casusconsulting.com/services/switzerland/device-registration/
    Switzerland Medical Device & IVD Registration Requirements. Due to larger political issues, the Switzerland-EU Mutual Recognition Agreement (MRA) has lapsed for medical devices and IVDs.. The Swiss regulations (MedDO and IvDO) require manufacturers to …

Medical Device registration in Switzerland - Thema Med

    https://www.thema-med.com/en/medical-device-registration-switzerland/
    In the meantime, Medical Devices placed on the Swiss market must comply with the MedDo (modified in May 2021), which sets numerous requirements. The timelines for affixing the …

Regulation of medical devices - Swissmedic

    https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices.html
    Medical devices are attributed to various risk categories that require varying assessment procedures. The visible result of a compliance assessment is the so-called CE label, which …

Swiss Single Registration Number (CHRN) - Swissmedic

    https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
    Based on the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR. 812.219) Swissmedic, the Swiss Agency for …

Switzerland Medical Device Registration - Swissmedic …

    https://arazygroup.com/medical-device-registration-switzerland/
    REGULATORY AUTHORITY:Medical device licensing in Switzerland is governed by Swissmedic, the Swiss agency for Therapeutic Devices. Devices are …

Placing Medical Devices on the Swiss Market After the EU MDR …

    https://www.emergobyul.com/news/placing-medical-devices-swiss-market-after-eu-mdr-date-application
    Swiss manufacturers, (or their ARs and importers) must register themselves with Swissmedic within three months after placing a device on the market (see Article …

Switzerland medical device registration, Swissmedic, …

    https://medicaldevices.freyrsolutions.com/medical-devices-regulatory-services-switzerland
    The medical device classification in Switzerland is similar to the EU MDR’s classification system. The devices are classified into four (04) classes – Class I, IIa, IIb and III. The …

Swiss Authorized Representatives for Medical Device

    https://decomplix.com/swiss-authorised-representatives-medical-device-manufacturers/
    Also, per Article 55 §1 of the MedDO and Article 48 §1 of the IvDO, the Swiss Authorised Representative needs to register for its economic operator role with …

MedReg register of medical professions - admin.ch

    https://www.bag.admin.ch/bag/en/home/berufe-im-gesundheitswesen/medizinalberufe/medizinalberuferegister-medreg.html
    Under the revised Swiss Medical Professions Act, as of 1 January 2018 anyone exercising a medical profession requiring a university qualification who works in Switzerland must be …

Registration in Switzerland: how to register at the canton

    https://www.expatica.com/ch/living/gov-law-admin/registering-at-your-address-in-switzerland-205673/
    Registration can take from one hour to half a day. In most Swiss cantons, you must register in person. Prepare all the necessary documents in advance, whether …



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